Vertebral Inflation Balloon Kit

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Description
A balloon catheter system used in kyphoplasty procedures to restore vertebral height and create a cavity for bone cement injection. It helps stabilize spinal fractures, relieve pain, and improve spinal alignment in patients with vertebral compression fractures.

Key Features

  • Restores vertebral body height
  • Creates a cavity for bone cement
  • Helps stabilize compression fractures
  • Supports pain relief and spinal alignment
  • Designed for minimally invasive kyphoplasty procedures

Manufacturer: Ningbo HICREN Biotechnology Co., Ltd / China

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To order, call: (+855) 093 265 939 (24/7 support)

Composition and function

  • Inflation device consist of injection part, pressure gauge, connecting tube and three-way cock. Injection part contains handle, core pin, rack, trigger, spring, limit block, sleeve, sleeve knob, rubber plug, rotary joint.
  • Single use surgery device, sterilized by Ethylene oxide and sealed package. Provided in sterilization status.

Model: SV240-20、SV240-25、SV240-30、SV240-40.

Diagram

Features

  • Pressure gauge has two measure units, atm/MPa and atm/psi, atm mark is outside, Mpa or psi unit should be marked inside.
  • Zero tick mark is between two units, positive pressure is from zero to right direction(clockwise), vacuum part is from zero to left direction(anticlockwise) .
  • Minimum division value of MPa is 0.1MPa, digit interval should be smaller than 0.5MPa; Minimum division value of atm is 1 atm, digit interval should be smaller than 6 atm; Minimum division value of psi is 50 psi, digit interval should be smaller than 100 psi.
  • There’s no mark in negative pressure area of the pressure gauge, should indicate the range of negative pressure(like fan area) and remark ‘VAC’ or ‘vacuum’ word.
  • Sterilized using Ethylene Oxide, residual Ethylene Oxide should not exceed 10ug/g.

Intended use

The product is used to compress the balloon of the vertebral body during percutaneous vertebroplasty to make the balloon swell.

Operation Method

Check the package and product before use, make sure the package is intact. Do not use if the package is damaged.

1. Preparation

  • Connect the three-way cock and connecting tube, pull the trigger, push the limit block into the groove of core pin, put out the core pin.
  • Turn off the valve of three-way cock, check if the indicator is deflected, or air leak in the device.
  • Turn off the valve of three-way cock, inject the contrast media to drain the air inside.
  • Take out the limit block, engage the rack and sleeve the remove the three-way cock.

2. Working process

  • Connect the inflation device to the balloon catheter by the rotary joint
  • Rotate the corn pin, inject the contrast media into balloon catheter to inflate the ballon.
  • When the pressure reach the required value, maintain the balloon pressure by engaging the rack and sleeve.
  • When the surgery is finished, pull the trigger and withdraw the handle to release the pressure, then remove the balloon catheter.

Contraindications

  1. Non hemolytic VCF patient.
  2. Patient with Disturbances Of Blood Coagulation.
  3. Patient with damaged posterior edge of the vertebral body fracture.
  4. Severe Cardiopulmonary disease patient.
  5. Patient intolerant with tumor cachexia in later stage.
  6. People with hemorrhagic tendency.
  7. Fever greater than 38°C or patient with inflammation at puncture site.
  8. Osteomyelitis or full body infection.
  9. Kyphotic bone mass, or posterior tumor mass endanger vertebral canal .
  10. Painless VCFS, or VCFS is not main reason.
  11. Patient without operative indication.
  12. Vertebral compression over 70%.
  13. Severe compression of spinal cord in diseased vertebral body, or secondary Spinal stenosis.

Complications

  • Infection (part of full body).
  • Injury to spinal cord or nerve root.

Warning, precautions

  • EO sterilization, not allow to be used if package is damaged.
  • Check if the indicator is deflected, or air leak in the device. If the indicator doesn’t move or there’s air leak of the device, product is not allowed to be used.
  • Make sure there is no bubble remaining after contrast media is injected into the sleeve.
  • Check the bursting pressure of balloon before connecting the catheter. Pressure can not be over the bursting pressure of balloon and the range of pressure gauge.
  • Inject the contrast media into the catheter, when the balloon inflated, the pressure gauge should face the operator.
  • When the pressure reach the required value, rotate the inflation device to make the mark face the operator in upright direction.
  • For single use only, reuse is strictly forbidden.
  • Products should be used by qualified health care people with professional training.

Storage: Store in clean, cool, dry place without corrosive gas, humidity should not be over 80%. [Transportation condition]: Avoid heavy load, direct sunlight, rain and snow.

Labelling, Symbols

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